Webinars

The BIO International Convention attracts 15,000+ biotechnology and pharma leaders for one week of intensive networking to discover new opportunities and promising partnerships. Position yourself for success at this year's event, June 3-6, in San Diego! BIO is where business and breakthroughs converge – and the BIO One-on-One Partnering™ system facilitates the connections that fuel our industry.

Attend this webinar to learn more about what’s happening at BIO 2024 and what the BIO One-on-One Partnering™ system can do for your business goals. Explore the program, networking opportunities, partnering system fundamentals, gain insight to best practices for partnering, and much more! For more information and to register for BIO 2024, please visit: convention.bio.org

Join BIO staff as they walk exhibitors through the tools needed to plan for BIO International 2024!

The goal of this webinar is to provide our exhibitors with the resources to have an impactful presence in San Diego as well as provide additional details.

The following topics will be discussed:

• Exhibitor Dashboard
• Exhibitor Resources
• Exhibitor Partnering
• Important Dates and Deadlines
• Frequently Asked Questions (FAQs)

The FDA has established the Split Real-Time Application Review (STAR) pilot program. The purpose of this program is to shorten the time from the date of a complete submission to the action date, in allowing earlier patient access to therapies that address an unmet medical need.

In this webinar, FDA staff will give an overview of the program, including the eligibility criteria for the pilot, and will answer your questions about participating in the program.

View this conversation highlighting how BIO member companies are leveraging biotechnology innovations to enable advances in climate adaptation, mitigation, and resilience. Hear how diverse feedstocks and manufacturing processes are targeting emission reduction breakthroughs in hard-to-reach sectors. Learn how regulation and policy can better incentivize innovation and be structured to support new and emerging technologies throughout research, development, demonstration, and deployment.

​It's been one year since the passage of the IRA. The Centers for Medicare & Medicaid Services has moved forward implementing the law's various provisions, including the new Medicare negotiation program and the redesign of the Medicare Part D benefit. Learn the latest developments from our panel of experts, including how the IRA is impacting biopharmaceutical companies today. Panelists delve into other important issues beyond the IRA, including new developments in Medicaid, 340B, and the emergence of Prescription Drug Affordability Boards in a number of states.  

Following reauthorization by Congress of the SBIR/STTR Programs in 2022, there are new rules companies should familiarize themselves with concerning required disclosures of foreign affiliations or relationships with foreign countries. In addition to mandating disclosures prior to receiving SBIR awards, companies must also regularly update NIH following any changes to a disclosure. View this webinar organized by the Biotechnology Innovation Organization (BIO) for a comprehensive discussion on how to effectively navigate these new rules as you apply for SBIR awards.

This webinar is co-hosted by the National Institutes of Health (NIH) Seed Office.

With the majority of biological studies conducted in academic settings but nearly all innovative new drug clinical trials sponsored by industry, improving translational research success rates for commercialization is critical to bringing new treatments to patients. Surveys of academic tech transfer offices and the biopharma industry executives working on such alliances cite as obstacles two highly controllable factors: disagreement about alliance performance metrics and misalignment of deal terms priorities. This panel discusses best practices for removing such obstacles to accelerate more promising ideas into clinical development for patients.

BIO's updated 2023 report, "U.S. Biotechnology Translational Research: Partnership Models, Management Principles, and Best Practices," is available for download at the link below.  The webinar also summarizes major findings from that BIO report as context for the panel discussion and audience Q&A.

The Cell and Gene Therapy (CGT) Science Series is a quarterly seminar series focused on scientific topics related to cell and gene therapy products. The CGT Science Series is intended to foster scientific exchange between the Biotechnology Innovation Organization (BIO), the American Society of Cell & Gene Therapy (ASGCT), and Center for Biologics Evaluation and Research (CBER) review staff on a variety of topics that span the CGT product lifecycle. The seminars are planned as 60-minute virtual webinars featuring a speaker from one of the three organizations. The CGT Science Series will enable a deep dive into a specific technical and/or scientific area. Topics in the series may include but are not limited to, nonclinical, CMC, clinical, or post-market phases of development related to CGT product lifecycle.

Moderator:
– Anne-Virginie Eggimann, Tessera

Opening Remarks:
– Cartier Esham, Chief Scientific Officer, Biotechnology Innovation Organization (BIO)

Speaker:
– Jing Liao, Director, Vector Development and Operations, Alexion Pharmaceuticals

This Biotechnology Innovation Organization (BIO) webinar explains that the days of the one-page marketing slicks are over, as companies and investors now expect brief “Pitch Decks” when engaging in conversations with them. This diverse panel of experts explain how to make an effective pitch to them, so that you can tailor your BIO partnering strategy to achieve a maximum ROI.

During this webinar, panelists discuss strategies for biotechnology companies to manage economic downturns and weakened investor interest in the biotech industry. Our expert panel of industry leaders share their insights and experiences on how to maintain momentum and emerge stronger during periods of economic uncertainty.

This webinar is designed to provide practical advice and actionable strategies that can be implemented immediately. The panel covers the following topics:

• Effective communication and investor relations strategies during economic downturns

• Actions biotechs can take to cut costs without sacrificing innovation and growth

• How to pitch to investors during weakened investor interest periods

U.S. Department of Justice (DOJ) statistics suggest that enforcement will be a top government priority in 2023, including for pharma/life sciences. Warning or untitled letters from the U.S. Food and Drug Administration (FDA) will serve as ammunition for DOJ cases. Statements about product safety will be heavily scrutinized.

Do you know what to watch out for? Has your company trained its employees and marketing agencies on how to appropriately implement the requirements for promotion? What activities require extra vigilance? The prior downturn in enforcement can be linked to the development of a response to COVID-19, which diverted government resources across the board. Now trends suggest the FDA, DOJ, and Office of Inspector General (OIG) will return to active healthcare enforcement in 2023 for violations of the Food Drug and Cosmetic Act (FDCA), False Claims Act and the Anti-Kickback Statute in part attributable to the goal of obtaining additional financial recoveries.

This webinar hosted by the Biotechnology Innovation Organization (BIO) has these learning objectives:
—Understand the current trends for government enforcement
—Dissect the compliance implications of increased enforcement on the industry
—Identify specific cases that are clear examples for company concern
—Isolate the key principles for avoiding violations

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through May 15, 2023
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The Center for Communication Compliance (CCC) helps biopharmaceutical companies achieve efficient, compliant innovation in a digital world through its proprietary on-demand business solutions in education, technology, and change management.

The CCC eLearning System has set an unmatched standard for confirming regulatory competency through engaging mastery tests and expert education content across more than a dozen course options.

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